WASHINGTON (AP) -- Government scientists gave a tentative endorsement to the first nasal-spray flu vaccine, while stressing that it's useful only for certain healthy people, not those most at risk of severe influenza.
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Dec. 19, 2002
By Robert H. Shmerling, M.D.
Harvard Medical School
How does this article relate to me?
Imagine getting all of your vaccinations by nasal spray instead of by injection. That day may soon be here. For some time, we've been hearing about the development of a flu vaccine provided by nasal spray instead of by injection (or "shot"). With some important limitations, it appears that the nasal spray version of the influenza vaccine will finally become a reality, perhaps by next fall. This could be important news because many people who should get the flu shot don't. One reason may be that they would rather avoid the needle stick required by the current vaccine. Particularly for children, a safe, effective and "needle-free" flu vaccination would represent a significant advance.
Unfortunately, FluMist, the vaccine that may soon be approved by the U.S. Food and Drug Administration, will probably not provide the ideal alternative to an injectable vaccine. Because of concerns about effectiveness and safety, advisers to the FDA recommended that it not be approved for those who most need influenza vaccination or would most appreciate the nasal spray option: young children, the elderly and those with asthma or other chronic lung disease. It appears that those groups will have to rely on the old injectable version, even if this new nasal spray is approved.
Because the nasal spray vaccine was not studied in older people, its effectiveness remains unproven in that age group. Demonstrating that a vaccine is effective in older people is important because the ability of the aging immune system to respond to a vaccine may diminish over time. An effective vaccine for the elderly is critical because influenza may cause serious complications in them.
For toddlers, the issue is safety: Although effective in 93 percent of recipients, the nasal spray vaccine was associated with an increased risk of wheezing or asthma attacks in children under age 5. Even for those ages 5 to 49 — the group for whom approval is most likely — effectiveness was far from perfect.
What changes do I need to make?
It's not too late if you have not yet had the vaccination for influenza this year. Remember that the vaccination should be received every year before flu season.
If there is no history to suggest an increased risk of an allergic reaction to the vaccine (such as reactions to prior vaccinations or to eggs), almost anyone requesting the injectable vaccine should receive it. If you belong to a group considered at high risk for complications of influenza (or are frequently exposed to others who are in a high risk group), you should strongly consider getting a yearly flu shot. Those considered at higher risk for complications of influenza include those who:
- Are 50 or older
- Have asthma, chronic lung disease or other serious, chronic illness
- Have diabetes or any condition or treatment known to suppress the immune system
- Live in a nursing home or other chronic care facility
- Are children older than 6 months of age and have certain medical conditions such as asthma, heart disease, sickle cell anemia, diabetes or HIV infection
While the flu is not serious in most cases, improving the vaccination rate among those at high risk for complications is serious — 20,000 deaths and 100,000 hospitalizations are due to influenza each year in the United States alone.
What can I expect in the future?
If you are a person for whom influenza vaccination is specifically recommended, there's a good chance you won't receive the nasal spray form any time soon. Look for the results of additional studies that include people of all ages and directly compare the older, injectable influenza vaccination with the new nasal spray. In particular, more convincing research on the nasal spray's safety and effectiveness among people older than 50 and younger than 5 will be important in deciding which type of vaccine you or your children should receive in the future. Because the new spray formulation has a live virus (rather than killed virus, as in the injectable form), concern has been raised that sneezing after receiving the vaccine could cause illness in others nearby if they have not also been vaccinated. That means there is bound to be more debate about this vaccine’s safety.
Finally, expect to hear more about new ways of delivering medicines in the future. Not long ago, you could take your medicine in only a few ways: There were pills, ointments and injections. Now, an increasing number of medications are available by patch, nasal spray, or oral inhalation. Researchers are actively exploring new ways of delivering medications into the body, especially for drugs that currently require an injection. In addition, more convenient combinations of medicines — including the approval earlier this week of a single injection of five vaccines — are now available or in development. All of this is good news if making medications and vaccinations easier to take can increase the number of people who will benefit from them.
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